HIV PreventionNCT04558554
Pharmacy Delivery to Expand the Reach of PrEP in Kenya
A study testing pharmacy-based PrEP delivery in people with HIV Prevention, run by University of Washington at 2 sites in Kenya.
Trial summary
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- pharmacy-based PrEP delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,216 participants
- Where
- 2 sitesKenya
- Study dates
- 26 Nov 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >=18 years
- Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only)
- Initiated PrEP at a project-affiliated clinic (Study 1b only)
- Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only)
- Able \& willing to provide written informed consent
Who cannot join
- Currently pregnant or breastfeeding (Study 1a \& 1b only)
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kenya Medical Research Institute
Kisumu
Kenya Medical Research Institute (Center for Clinical Research - PHRD Thika-Project)
Thika
About this study
Official title: Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
Read the detailed description
Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers' unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP - including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills - are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. Prior formative qualitative research and a stakeholder meeting led to development of a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We will conduct 3 separate, consecutive studies.
During Study 1a (13 months), we will pilot this care pathway in 2 retail pharmacies evenly split between 2 different geographies in Kenya: Kisumu and Thika. Activities will include data collection aimed at potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.
During Study 1b (12 months, happening concurrently with Study 1a), we will additionally offer pharmacy-based PrEP refills only to clients who initiated PrEP at select public health clinics, to assess how many clients opt to refill PrEP at a study pharmacy (for a fee) as opposed to at the clinic (for free).
During Study 2 (6 months, happening right after Study 1a), we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Study 1a, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.
- Conditions
- HIV Prevention
- Being tested
- pharmacy-based PrEP delivery
- Keywords
- pre-exposure prophylaxis, Kenya, pharmacy, HIV self-testing, care pathway, pilot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacy-based PrEP deliveryOther
The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.
| Study group | Role | What they receive |
|---|---|---|
| Study 1a: Pharmacy-based PrEP delivery Pilot (13 months) | Experimental | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya. Receives: Other: pharmacy-based PrEP delivery |
| Study 1b: Pharmacy-based PrEP delivery Refill (12 months) | Experimental | Participants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics. Receives: Other: pharmacy-based PrEP delivery |
| Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months) | Experimental | Participants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. Receives: Other: pharmacy-based PrEP delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PrEP Initiation
Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.
Measured: Over 13-month duration of Study 1a and 6-month duration of Study 2
PrEP Retention
For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy.
Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic.
Measured: Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2
Secondary outcomes (7)
PEP Initiation
Study 2: Number of participants who initiated PEP at a pilot pharmacy.
Measured: Over 6-month duration of Study 2
Selection of Pharmacy-based PrEP Refills
Study 1b: Percentage of participants who initiated PrEP at a clinic and subsequently opted to refill their PrEP prescription at a pilot pharmacy.
Measured: During the 12-month duration of Study 1b
PrEP Adherence
Study 1a and Study 2: Percentage of randomly selected DBS samples with drug concentrations indicating PrEP adherence
Measured: Over 12-month duration of Study 1a and the 6-month duration of Study 2
STI Testing Uptake
Study 2: Number of participants who opt to undergo STI testing (provide a urine sample for lab-based testing) at pilot pharmacies
Measured: Over 6-month duration of Study 2
Transition From PEP to PrEP
Study 2: Percentage of participants who completed the full PEP regimen and subsequently initiated PrEP at a pilot pharmacy, among those who initiated PEP at a pilot pharmacy,
Measured: Over 6-month duration of Study 2
PrEP Initiation Among STI Testing Clients
Study 2: Number of participants who come to a study pharmacy for STI testing, undergo STI testing, and initiate PrEP at the pilot pharmacy during the same study visit or a subsequent study visit
Measured: Over 6-month duration of Study 2
Selection of Option to Self-administer HIV Risk Assessment Screening Tool
Study 2: Number of participants who opt to self-administer the HIV Risk Assessment Screening Tool (as opposed to having the pharmacy provider administer it)
Measured: Over 6-month duration of Study 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start26 Nov 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- During Studies 1a, 1b, and 2, all individuals meeting study and PrEP eligibility criteria will have the option Study 2, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Study 2, a subset of four study pharmacies (2 per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
- Masking
- None (open label)
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Katrina Ortblad, University of Washington
- Investigators
- Katrina Ortblad, MPH, ScD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558554
- Sponsor's protocol ID
- STUDY00009587
- Other IDs
- R34MH120106, P30AI027757
- Status last verified
- Feb 2024
- First submitted
- 5 Jun 2020
- Last updated
- 15 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ortblad KF, Kuo AP, Mogere P, Roche SD, Kiptinness C, Wairimu N, Gakuo S, Baeten JM, Ngure K. Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya. BMC Health Serv Res. 2024 May 11;24(1):618. doi: 10.1186/s12913-024-10995-0.
PubMed 38730398Ortblad KF, Mogere P, Omollo V, Kuo AP, Asewe M, Gakuo S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi EA, Ngure K, Baeten JM. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 2023 Jun;26(6):e26131. doi: 10.1002/jia2.26131.
PubMed 37306128Omollo V, Asewe M, Mogere P, Maina G, Kuo AP, Odoyo J, Oware K, Baeten JM, Kohler P, Owens T, Bukusi EA, Ngure K, Ortblad KF. The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya. J Acquir Immune Defic Syndr. 2023 Aug 15;93(5):379-386. doi: 10.1097/QAI.0000000000003208.
PubMed 37079900
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacy Delivery to Expand the Reach of PrEP in Kenya: Pilot Study
- ClinicalTrials.gov ID
- NCT04558554
- Acronym / sponsor ID
- STUDY00009587
- Conditions
- HIV Prevention
- Keywords
- pre-exposure prophylaxis, Kenya, pharmacy, HIV self-testing, care pathway, pilot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), National Institute of Allergy and Infectious Diseases (NIAID), Bill and Melinda Gates Foundation
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Posted 15 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
3 consecutive studies to test a novel model for PrEP initiation and refills in Kenya: pharmacy-based PrEP delivery.
Detailed description
Pre-Exposure Prophylaxis (PrEP) is a new HIV prevention method that works when taken as recommended. To take full advantage of public health benefit of PrEP for HIV prevention, there is need to prioritize access, minimize costs of delivery, and reach out to at-risk populations. In Africa, PrEP is being added to a public health infrastructure which is sometimes burdened by overcrowding and drug stock outs; the ability of health systems to maximize PrEP access necessitates finding novel delivery strategies. Additionally, there exist major barriers to PrEP delivery, which includes stigma, long waiting times, costs of staffing and healthcare providers' unfamiliarity with delivering prevention interventions. In Kenya, and many other resource-limited countries, retail pharmacies (i.e., chemists) fill an important gap in the health care system providing first stop access to treatment, monitoring and preventive care of urgent and prolonged conditions. Potential PrEP users may desire pharmacy-delivered PrEP over facility-delivered PrEP for reasons including increased convenience, increased privacy and greater engagement compared to health facilities that focus on treating ill patients. Retail pharmacies can offer free, subsidized or affordable healthcare services. The core components of PrEP - including HIV testing, adherence and risk reduction counselling, assessment of side effects and provision of refills - are within the scope of practice for pharmaceutical technologists and pharmacists in Kenya. Prior formative qualitative research and a stakeholder meeting led to development of a care pathway for pharmacy-based PrEP delivery (including initiation and refills), endorsed for piloting in a consultation meeting that included a wide spectrum of regulatory, professional, government, and community stakeholders in Kenya. We will conduct 3 separate, consecutive studies.
During Study 1a (13 months), we will pilot this care pathway in 2 retail pharmacies evenly split between 2 different geographies in Kenya: Kisumu and Thika. Activities will include data collection aimed at potential weak points of pharmacy-based PrEP delivery, in domains relating to acceptability, fidelity, and costs.
During Study 1b (12 months, happening concurrently with Study 1a), we will additionally offer pharmacy-based PrEP refills only to clients who initiated PrEP at select public health clinics, to assess how many clients opt to refill PrEP at a study pharmacy (for a fee) as opposed to at the clinic (for free).
During Study 2 (6 months, happening right after Study 1a), we will modify the delivery model (e.g., add new implementation strategies) to address the weak points identified during Study 1a, and we will expand PrEP delivery to six additional retail pharmacies (for a total of 12 pharmacies), evenly split between Kisumu and Thika.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- During Studies 1a, 1b, and 2, all individuals meeting study and PrEP eligibility criteria will have the option Study 2, study pharmacies will also offer post-exposure prophylaxis (PEP) for HIV prevention to individuals meeting study and PEP eligibility criteria. Also during Study 2, a subset of four study pharmacies (2 per region) will offer STI testing and treatment to individuals meeting study eligibility criteria.
| Arm | Type | Receives |
|---|---|---|
| Study 1a: Pharmacy-based PrEP delivery Pilot (13 months) | Experimental | Other: pharmacy-based PrEP deliveryParticipants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) at 4 retail pharmacies in Kenya. |
| Study 1b: Pharmacy-based PrEP delivery Refill (12 months) | Experimental | Other: pharmacy-based PrEP deliveryParticipants in this study (happening concurrently with Study 1a) will have the option to refill PrEP at 4 retail pharmacies in Kenya after having initiated PrEP at one of 2 public clinics. |
| Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months) | Experimental | Other: pharmacy-based PrEP deliveryParticipants in this study will have the option to initiate and/or refill pre-exposure prophylaxis (PrEP) or initiate PEP at 12 retail pharmacies in Kenya. Additionally, at a subset of 4 pharmacies, participants will have the option to undergo STI testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- >=18 years
- Interested in initiating PrEP at a pilot pharmacy (Study 1a and Study 2), interested in refilling PrEP at a pilot pharmacy (Study 1b), or interested in initiating PEP and/or STI testing at a pilot pharmacy (select pharmacies in Study 2 only)
- Initiated PrEP at a project-affiliated clinic (Study 1b only)
- Meets all criteria (e.g., tests HIV-negative) on checklist for initiating and/or refilling PrEP (all phases), PEP (Study 2 only), and/or STI testing (Study 2 only)
- Able \& willing to provide written informed consent
Key exclusion criteria (1 listed)
- Currently pregnant or breastfeeding (Study 1a \& 1b only)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmacy-based PrEP deliveryThe intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery. | Other | Study 1a: Pharmacy-based PrEP delivery Pilot (13 months), Study 1a: Pharmacy-based PrEP delivery Pilot Extension (6 months), Study 1b: Pharmacy-based PrEP delivery Refill (12 months) |
Primary outcome
PrEP Initiation
Time frame: Over 13-month duration of Study 1a and 6-month duration of Study 2
Cumulative number of participants who initiated PrEP at pilot pharmacies (during Study 1a and Study 2) among those eligible for pharmacy PrEP services.
PrEP Retention
Time frame: Over 13-month duration of Study 1a, 12-month duration of Study 1b, and 6-month duration of Study 2
For Study 1a and 2: Percentage of participants who refilled PrEP at a pilot pharmacy, among those who initiated PrEP at a pilot pharmacy. Study 1b: Percentage of participants who refilled PrEP either at a pilot pharmacy or at a pilot clinic, among those who initiated PrEP at a pilot clinic.
7 secondary outcomes
PEP Initiation
Time frame: Over 6-month duration of Study 2
Selection of Pharmacy-based PrEP Refills
Time frame: During the 12-month duration of Study 1b
PrEP Adherence
Time frame: Over 12-month duration of Study 1a and the 6-month duration of Study 2
STI Testing Uptake
Time frame: Over 6-month duration of Study 2
Transition From PEP to PrEP
Time frame: Over 6-month duration of Study 2
PrEP Initiation Among STI Testing Clients
Time frame: Over 6-month duration of Study 2
Selection of Option to Self-administer HIV Risk Assessment Screening Tool
Time frame: Over 6-month duration of Study 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38730398Ortblad KF, Kuo AP, Mogere P, Roche SD, Kiptinness C, Wairimu N, Gakuo S, Baeten JM, Ngure K. Low selection of HIV PrEP refills at private pharmacies among clients who initiated PrEP at public clinics: findings from a mixed-methods study in Kenya. BMC Health Serv Res. 2024 May 11;24(1):618. doi: 10.1186/s12913-024-10995-0.
- Derived from this study: PubMed 37306128Ortblad KF, Mogere P, Omollo V, Kuo AP, Asewe M, Gakuo S, Roche S, Mugambi M, Mugambi ML, Stergachis A, Odoyo J, Bukusi EA, Ngure K, Baeten JM. Stand-alone model for delivery of oral HIV pre-exposure prophylaxis in Kenya: a single-arm, prospective pilot evaluation. J Int AIDS Soc. 2023 Jun;26(6):e26131. doi: 10.1002/jia2.26131.
- Derived from this study: PubMed 37079900Omollo V, Asewe M, Mogere P, Maina G, Kuo AP, Odoyo J, Oware K, Baeten JM, Kohler P, Owens T, Bukusi EA, Ngure K, Ortblad KF. The Fidelity of a Pharmacy-Based Oral HIV Pre-Exposure Prophylaxis Delivery Model in Kenya. J Acquir Immune Defic Syndr. 2023 Aug 15;93(5):379-386. doi: 10.1097/QAI.0000000000003208.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina Ortblad, MPH, ScD principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmacy-based PrEP delivery in people with HIV Prevention, run by University of Washington at 2 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PrEP Initiation (time frame: Over 13-month duration of Study 1a and 6-month duration of Study 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558554, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.